Oestrogen Treatment for COVID-19 Symptoms
The Impact of Oestrogen Administration on Covid-19 Disease
1 other identifier
interventional
2,000
1 country
1
Brief Summary
The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started May 2021
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 21, 2021
March 1, 2021
10 months
April 6, 2021
April 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evidence of disease progression for mild cases
Proportion hospitalised within 28 days
28 days
Evidence of disease progression in hospitalised patients (moderate and severe cases)
Proportion requiring mechanical ventilation or dying within 28 days
28 days
Secondary Outcomes (6)
Hospital mortality
28 days
Duration of hospital admission
28 days
Admission to ICU/ HDU facility
28 days
Need for renal replacement therapy
28 days
Ventilation
28 days
- +1 more secondary outcomes
Study Arms (2)
Oestrogen Therapy
ACTIVE COMPARATORPatients will receive standard care + transdermal 17ß-estradiol gel (3 mg) for ten days.
Control Group
NO INTERVENTIONPatients will receive only standard care.
Interventions
Patients will receive standard care +/- (randomsed 1:1) transdermal 17ß-estradiol gel (3 mg; applied to forearm, upper arm and shoulder) for ten days.
Eligibility Criteria
You may qualify if:
- Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)
- Adult males \> 18 years of age OR
- Post-menopausal women (spontaneous amenorrhoea for \>12 months in the absence of any other cause)
You may not qualify if:
- Women:
- taking oestrogen supplements or oestrogen receptor antagonists
- with abnormal genital bleeding
- with a history of breast cancer
- with a history of endometrial or ovarian cancer
- with untreated endometrial hyperplasia
- Men:
- taking hormone therapies (e.g. for prostate cancer)
- Any subject:
- failure to obtain consent
- taking lamotrigine
- with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)
- with pre-existing liver or renal disease
- with known allergy to exogenous oestrogens
- with a history of porphyria
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamad Medical Corporationlead
- Laboratoires Besins Internationalcollaborator
Study Sites (1)
Hamad Medical Corporation
Doha, PO Box 3050, Qatar
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 21, 2021
Study Start
May 17, 2021
Primary Completion
February 28, 2022
Study Completion
March 31, 2022
Last Updated
April 21, 2021
Record last verified: 2021-03